Pradaxa dabigatran etexilate regulatory update

FDA's Cardiovascular and Renal Drugs Advisory Committee voted 9-0 that Boehringer's Pradaxa dabigatran should be approved for the reduction of stroke and non-CNS systemic embolism in patients with non-valvular atrial fibrillation (AF). The committee made its decision based on results from the Phase III RE-LY trial, which showed that each dose of Pradaxa studied (110 and 150 mg twice daily) was non-inferior to open-label, adjusted-dose warfarin on the primary endpoint of reduced stroke and systemic embolism, as well as the main safety endpoints of prespecified categories of bleeding (see BioCentury, Sept. 7, 2009). ...